GUEST CONTRIBUTORS

  • 5 Keys To Unlock The Full Potential Of Big Data In The Life Sciences
    5 Keys To Unlock The Full Potential Of Big Data In The Life Sciences

    The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.

  • How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access
    How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access

    Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?

  • Challenges Implementing New Advanced HFE testing Methods
    Challenges Implementing New Advanced HFE testing Methods

    Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.

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PHARMA OUTSOURCING WHITE PAPERS

Choosing The Best Sterile Dosage Form For Your Phase I  Clinical Supply Needs Choosing The Best Sterile Dosage Form For Your Phase I Clinical Supply Needs

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.

In-House Versus Outsource: A Decision-Making Guide In-House Versus Outsource: A Decision-Making Guide

Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

BioProcess Containers – Materials Of Construction

Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

Multiplexing: Managing Risk With Proven, Single-Use Solutions

With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Are Today’s Processes Efficient Enough For The Future Of Vaccine And Viral Vector Production?

By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.

Resolving Bottlenecks of Recombinant Antibody Fragments

Antibodies and their derivatives are increasingly important and essential tools for biological research. Techniques to screen and characterize large numbers of antibodies and provide confident selection of the best candidates for development are therefore essential. Details described in this method will provide rapid screening in combination with data-rich selection of fragments with high affinity and the desired kinetic behavior.

Choosing Your Single-Use Technology Supplier

To be credible, a partner needs to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training.

A Call To Action: Industry Innovators Seek New Technologies To Advance Personalized Medicine

Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing. 

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

DCAT Sharp Sourcing 2018 June 26, 2018
New Brunswick, NJ)
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements June 26 - 26, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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